BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LENSX LASER SYSTEM

    MDR report key: 3770982 · Received December 18, 2013

    Report

    Report Number
    3008772169-2013-00109
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    December 3, 2013
    Report Date
    December 4, 2013
    Manufacturer
    ALCON - LENSX LASER, INC.
    Product Code
    OOE
    PMA / PMN Number
    K101626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED MULTIPLE POSTERIOR CAPSULE TEARS AFTER FEMTOSECOND LASER TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664180 LENSX LASER SYSTEM OPTHALMIC FEMTOSECOND LASER OOE ALCON - LENSX LASER, INC. 550 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other